Authored by Michael J. Flibbert, Denise Main, Ph.D. and Christopher L. McDavid
Modern research typically requires joint effort, and this remains true in the field of chemistry. Different individuals—or even different teams—may be involved in designing chemical structures, creating synthesis routes and evaluating candidate compounds in in vitro or in vivo screening assays.
These persons may work in separate locations, at different times, and their individual contributions may range from truly vital to fairly insignificant. Some team members may apply innovative techniques while others simply follow routine procedures well known in the art. If this joint effort yields a new and useful compound or class of compounds, who should be named as the inventor(s) in any patent application?
Answering this question can be particularly vexing since chemical patent practitioners are adept at Drafting claims of wildly varying scope: A narrow "species" claim covers only a single chemical compound of specific structure while a broad "genus" claim may cover literally trillions of related compounds of varying structure.1 Moreover, most chemical patent applications include species claims, genus claims and various method claims.
Under 35 United States Code (USC) § 116, inventors may apply for a patent jointly even though they did not physically work together or at the same time, did not make the same type or amount of contribution and did not all contribute to the subject matter of every claim. Further, under Federal Circuit case law, conception remains the touchstone of inventorship. For a chemical compound, conception requires knowledge of both the compound's specific chemical structure and an operative method of making it.2 And although each co-inventor must contribute in some significant way to the conception of the claimed invention, each need not alone conceive of the entire claimed invention as that would obviate the concept of joint inventorship.3
The Federal Circuit's recent decision in Falana v Kent State University4 applied Fina Oil in affirming a district court's decision that a researcher who created a method of making a novel genus of chemical compounds should have been named as a joint inventor of claims covering a subset of compounds within that genus. Yet, as will be discussed, this decision leaves unanswered whether one who creates a method of making a genus should be considered a co-inventor each species falling within the genus. Further, the case starkly illustrates that institutions that fail to obtain contractual obligations to assign rights from all potential joint inventors risk becoming mired in years of otherwise avoidable litigation.
Dr. Alexander Seed, an associate professor at Kent State University, in collaboration with Kent Displays (KDI), hired Dr. Olusegun Falana to synthesise temperature-independent, high helical twisting power chiral additives to improve the performance of liquid crystal displays. Dr. Seed expected Dr. Falana to work independently on the project. Both Dr. Seed and Dr. Falana were listed as "Co-Research Institution Investigators" on grant applications filed with the National Science Foundation.
During his employment, Dr. Falana developed a synthesis protocol for making a novel class of chemical compounds called naphthyl substituted TADDOLS. His synthesis protocol could be used to make both "S,S" and "R,R" enantiomers of these compounds. Enantiomers are molecules that are non- superimposable mirror images of each other.
Using his synthesis protocol, Dr. Falana made naphthyl substituted TADDOLS of his own design as well as those suggested by Dr. Seed. Dr. Falana made an S,S enantiomer known as "Compound 7," which represented significant progress but did not completely satisfy the project’s goal of discovering a chiral additive that would be stable across a broad temperature range. Dr. Falana resigned from Kent State and KDI in 1999 to take another position. It appears that Kent State and KDI never obtained any contractual obligation from Dr. Falana to assign to them his rights in any inventions made during his employment.
In early 2000, Dr. Seed synthesised "Compound 9," another novel naphthyl substituted TADDOL, using Dr. Falana's synthesis protocol. Unlike Compound 7, which Dr. Falana had made, Compound 9 was an R,R enantiomer and exhibited improved temperature stability characteristics, thus satisfying the project's goal.
Ultimately, Kent State and KDI obtained US Patent No 6,830,789 ("the '789 patent") disclosing Dr. Falana's synthesis protocol as the only method of synthesis, but claiming only a subset of the naphthyl substituted TADDOL genus - the R,R enantiomers. And while Dr. Falana was included as a co-author of a publication describing the naphthyl substituted TADDOL genus of R,R and S,S enantiomers (including Dr. Falana's Compound 7 and Dr. Seed's Compound 9), he was not identified as a co-inventor on the '789 patent covering the subgenus of R,R enantiomers.
Dr. Falana brought an action under 35 USC § 256 alleging that he was omitted as a joint inventor of the '789 patent. After a bench trial, the US District Court for the Northern District of Ohio ruled for Dr. Falana, finding that he contributed significantly to the conception of the claimed invention because he developed the synthesis protocol used to make the subgenus of compounds claimed in the '789 patent. Defendants Kent State and Dr. Seed appealed.
The Federal Circuit's Decision
On appeal, the defendants argued that although Dr. Falana created the synthesis protocol used to make the subgenus of compounds claimed in the '789 patent, his contribution was legally insufficient to make him a joint inventor because the patent claims were directed to chemical compositions, not to methods. The Federal Circuit disagreed, stating that where a method requires more than the exercise of ordinary skill, "the discovery of that method is as much a contribution to the compound as the discovery of the compound itself."5 The court further held that, consistent with its earlier decision in Fina Oil, "a putative inventor who envisions the structure of a novel genus of chemical compounds and contributes the method of making that genus contributes to the conception of that genus."6
As the district court found, Dr. Falana discovered the method used to make the R,R subgenus of compounds covered by the claims, exercised more than ordinary skill, and did not simply follow the teachings of others. These factual findings were apparently unchallenged on appeal. Dr. Falana thus contributed to the conception of the claimed genus, the Federal Circuit held, by providing the team of which he was a part with the method for making these novel compounds.7
The Federal Circuit also rejected the argument that Dr. Falana did not contribute to the conception of the claims because Compound 9 was first made after he left the team. The claims of the '789 patent, the court explained, were not limited to Compound 9 but covered the R,R enantiomer subset of the entire genus of naphthyl substituted TADDOLs.8 The Federal Circuit therefore affirmed the district court's judgment of joint inventorship.
Implications for practitioners
Falana applies the rule of Fina Oil and prior precedent that conception of a chemical compound requires knowledge of both the compound's structure and an operative method of making it. Notably, the Federal Circuit cites no evidence that Dr. Falana ever knew of the structure of the claimed compounds, which were R,R enantiomers. Dr. Falana's Compound 7 was an S,S enantiomer outside the scope of the claims. But, as the court had previously explained in Fina Oil, although each co-inventor must contribute in some significant way to the conception of the claimed invention, each need not alone conceive of the entire claimed invention as that would obviate the concept of joint inventorship. Here, as the Federal Circuit ultimately held, Dr. Falana contributed to the conception of the claimed genus by providing the team of which he was a part with the method for making these novel compounds. In view of this substantive contribution, no more was required for joint inventorship. Endnotes
As the court clarified, however, such a contribution does not necessarily convey inventorship rights to all future species made using the novel method. Once the method becomes publicly known, its use comprises ordinary skill in the art.9 In addition, collaboration is always required for joint invention.
Apart from these limitations, it remains unclear whether discovery of a method of making a chemical genus establishes joint invention of particular species made by collaborators using the method. If the '789 patent had claimed only Dr. Seed's Compound 9, for example, would the court have affirmed a conclusion of joint inventorship? Arguably, Dr. Falana did not know of the specific chemical structure of Compound 9. But, again, since it is unnecessary for a joint inventor to conceive of the entire claimed invention, Dr. Falana's creation of a novel method to make Compound 9 could be viewed as significantly contributing to the overall conception of the compound, justifying joint inventorship. We will have to wait for future to decisions clarify this area of uncertainty.
Because the law of joint inventorship continues to evolve, practitioners should carefully document the inventive process, including investigating and identifying the sources of all contributions to the method of making a claimed chemical compound or composition. One must also consider whether such contributions required more than the exercise of ordinary skill. This determination may depend on the state of the prior art, the sophistication of the technology, and the experience and educational levels of workers in the field. One must also consider the breadth of the claims, recognising that broad genus claims may create more inventorship issues than narrow species claims. When in doubt, practitioners should err on the side of including as co-inventors all individuals who arguably made some substantive contribution to the subject matter of at least one claim.
In addition, the Falana decision shows the unfortunate consequences of failing to secure a contractual obligation to assign from all potential co-inventors. Kent State and KDI do not appear to have obtained any contractual obligation from Dr. Falana to assign to them his rights in any invention made during his employment. Consequently, nearly four years after Dr. Falana filed suit in March 2008, the parties are still litigating. Indeed, because the District Court found the case to be exceptional under 35 USC § 285 they are now litigating Dr. Falana's entitlement to an award of attorney fees. Years of litigation likely could have been avoided through a simple agreement conveying Dr. Falana's rights in any invention to his employers. Although educational institutions such as Kent State may experience resistance from academic researchers to assignment agreements, such agreements may avoid costly and disruptive patent litigation when disputes over joint inventorship arise.
1 See eg, Otsuka Pharmaceutical Co, Ltd v Sandoz, Inc, No 3:07-cv-01000, 2010 WL 4596324 at *3 (DNJ 201 0) (discussing chemical patent covering approximately nine trillion compounds).
2 See eg, Fina Oil & Chem Co v Ewen, 123 F3d 1466, 1473 (Fed Cir 1997).
4 Falana v Kent State Univ, No 2011-1 198 (Fed Cir 23 January 2012).
5 Id, slip opinion at 15.
7 Id at 17.
9 Id at 15-16.
Originally printed in Intellectual Property Magazine (www.intellectualpropertymagazine.com). Reprinted with permission. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.